COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04486508

Parham Sadeghipour, MD

psadeghipour@hotmail.com

2020-07-24

Completed

RCT

Randomized

Factorial

Blind label

single-center

Treatment

inclusion criteria for anticoagulation hypothesis adult patients (≥18 years), with polymerase chain reaction (pcr)-confirmed covid-19 admitted to icu within 7 days of initial hospitalization , who do not have another firm indication for anticoagulation (such as mechanical valve, high-risk atrial fibrillation (af), vte, or left ventricle (lv) thrombus),who are not enrolled in another blinded randomized trial, and are willing to participate in the study and provide informed consent . estimated survival of at least 24 hours at the discretion of enrolling physician exclusion criteria for anticoagulation hypothesis weight <40 kilogram (kg) overt bleeding at the day of enrollment known major bleeding within 30 days (according to the bleeding academic research consortium (barc) definition, appendix a) platelet count <50,000/fl pregnancy (as confirmed by beta human chorionic gonadotropin (hcg) testing among female patients <50 years) patients on extracorporeal membrane oxygenation (ecmo) history of heparin induced thrombocytopenia or immune thrombocytopenia ischemic stroke within the past 2 weeks craniotomy/major neurosurgery within the past 3 months major head or spinal trauma in the past 30 days known brain metastases or vascular malformations (aneurysm) presence of an epidural, spinal or pericardial catheter major surgery other than neurosurgery within 14 days prior to enrollment coexistence of severe obesity (weight >120 kg or bmi>35 kg/m2 along with severe renal insufficiency defined as creatinine clearance (crcl) <30 ml/sec) allergic reaction to study medications lack or withdrawal of informed consent inclusion criteria for the statin randomization patients enrolled for the anticoagulation randomization willingness to participation in the study and providing informed consent exclusions criteria for the statin randomization baseline liver function tests> 3 times upper normal limits (uln) or creatine kinase (ck) >500 u/l active liver disease (lft>3 uln plus histologic finding including cirrhosis or inflammation or necrosis) routine use of statins prior to the index hospitalization previous documented statin intolerance

None

4

Rajaie Cardiovascular Medical and Research Center

18

100

Iran;Islamic Republic of

Critical disease at enrollment

8: Critical disease at enrollment

600

a composite of acute VTE, arterial thrombosis, treatment with ECMO, or all-cause mortality

None

Phase 3

[{"arm_notes": "", "treatment_id": 464, "treatment_name": "Enoxaparin or unfractionated heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 464, "treatment_name": "Enoxaparin or unfractionated heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]